In response to the notice published February 24, 1999, in the Federal Register, the ASM would like to comment on the proposed rule on the irradiation of meat and meat products.

The American Society for Microbiology (ASM) is the premier educational, professional and scientific society dedicated to the promotion of the microbiological sciences and their applications for the common good. The Society represents more than 42,000 microbiologists, including scientists and science administrators in academic, industrial and government institutions working in a variety of areas, including applied and environmental microbiology, food science, and medical microbiology.

Food irradiation is a safe and effective processing method for enhancing the safety of food. Processing of foods by irradiation should be approved for use on ingredients and finished food products where there is a clear benefit to safety. Special labeling of irradiated foods is not scientifically-based because irradiation was misclassified as a food additive by rulemaking.

There are substantial data supporting the effectiveness of irradiation for significantly reducing or eliminating microbial pathogens in raw meat. The doses that are proposed, i.e. 4.5 kGy for refrigerated and 7.0 kGy for frozen meat, should suffice for decreasing to undetectable populations the levels of bacterial foodborne pathogens normally associated with raw meats. However, there is no need to propose a minimum level of irradiation for meat or poultry products. Rather, meat and poultry processors should be allowed to determine the level of irradiation that is appropriate for pathogen control in their specific products.

Food irradiation may eliminate pathogens in meat products; however, recontamination of such foods by food handlers can occur after the packaged product is opened. The ASM emphasizes that irradiation is not a substitute for safe food handling practices. Consumers and food retailers should be made aware of potential safety problems that may arise from post-irradiation contamination of opened products.

If packaged meat and poultry products containing the radura symbol are sent to a separate facility for irradiation, then the product prior to irradiation should technically be considered misbranded. However, provisions should be made to ensure that local inspectors do not consider such products as truly misbranded, as long as proper shipping and receiving controls are in place.

FSIS should include provisions to allow the irradiation of hot-boned meat which is supported by an FDA assessment that the safety of irradiating refrigerated meat is completely applicable to hot-boned meat. Hot-boned meat should be included in the final irradiation rule issued by FSIS. However, the maximum dose may need to be adjusted depending on product temperature during exposure to radiation.

Uniformity of labeling of all irradiated products should be required. It is not necessary to require that the statement identifying irradiated product appear as a qualifier contiguous to the product name; however, including the radura symbol and a statement indicating that the product has been irradiated is necessary for consumer information. Placing the radura symbol and labeling statement in a prominent and conspicuous location on the label should be sufficient.

Incentive labeling for both meat and poultry such as "Treated by irradiation to reduce Salmonella and other pathogens" should be allowed. However, care should be taken to avoid the use of potentially misleading statements such as "elimination of" or "free of" when a treatment may only provide substantial "reduction of." Incentive labeling requirements should allow the flexibility of making additional claims providing that they are scientifically substantiated. It will be necessary to establish minimum requirements if terms like "pathogen free" are allowed. Such minimum requirements could be defined in terms of performance criteria (e.g., 5D kill of E. coli O157:H7).

Preapproval of labeling on irradiation would slow product introductions with little benefit. Hence, such approvals should not be required. Rather, companies should be required to conform to the stated requirements including the generation of data to support any incentive labeling claims and should be required to produce such data.

Finally, FSIS should consider incorporating a "sunset" provision in their labeling document. Since irradiation is a proven safe and effective technology, there seems to be little value in bringing overt attention to its use. For example, a symbol similar to the radura symbol is not required for "pasteurized" products or products containing preservatives. Therefore, it seems reasonable that a "sunset" provision be included after some reasonable period of time.

The ASM is pleased to have the opportunity to provide comments in response to the proposed rule for irradiation of meat and meat products and hopes that these comments and recommendations provide assistance.